MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-02-23 for CHATTANOOGA 2788 manufactured by Djo Llc.
[16173328]
Per 21cfr part 803, an mdr reportable event. Complaint received from clinician that alleges "patient recd. Third degree burns while receiving treatment". Questionnaire was received from clinician and/or patient. Questionnaire states progress towards recovery was not impeded, treatment with silvadene ointment initiated. Device not returned to manufacturer for evaluation. No indication event caused or contributed to permanent impairment or death.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616086-2015-00005 |
| MDR Report Key | 4630156 |
| Report Source | 05 |
| Date Received | 2015-02-23 |
| Date of Report | 2015-03-23 |
| Date of Event | 2015-03-10 |
| Date Added to Maude | 2015-03-26 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 140 DECISION ST. |
| Manufacturer City | VISTA CA 92081 |
| Manufacturer Country | US |
| Manufacturer Postal | 92081 |
| Manufacturer Phone | 7607271280 |
| Manufacturer G1 | DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V. |
| Manufacturer Street | CARRETERA LIBRE TIJUANA TECATE 20230 SUBMETROPOLI EL FLORIDO |
| Manufacturer City | TIJUANA B.C. 22244 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 22244 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CHATTANOOGA |
| Generic Name | LEGEND XT |
| Product Code | IMG |
| Date Received | 2015-02-23 |
| Model Number | 2788 |
| Operator | HEALTH PROFESSIONAL |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DJO LLC |
| Manufacturer Address | 1430 DECISION ST. VISTA CA 92081 US 92081 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-02-23 |